Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety of a study drug known as LY3090106 in healthy Caucasian and Japanese participants. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug. The study will last about 12 weeks, not including screening or additional follow-up.
Interventions
DRUGLY3090106
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy Japanese or Caucasian * Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)
Exclusion criteria
* Have participated, within the last 30 days, in a clinical study involving an investigational product (IP). If the previous IP has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed * Have had symptomatic herpes zoster within 3 months of screening * Show evidence of active or latent tuberculosis (TB) * Have known hypogammaglobulinemia or a screening serum immunoglobulin (Ig) G \<565 milligrams per deciliter (mg/dL) * Have received live or attenuated vaccine(s) within 1 month of screening, or intend to during the study * Are immunocompromised * Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. Participants with any prior exposure to ixekizumab, tabalumab or other biologic agents directly targeting Interleukin 17 (IL-17) and/or B cells (e.g., rituximab, belimumab, etc.) are excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 85 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Drug Concentration (Cmax) of LY3090106 | Baseline through Day 85 | Cmax of LY3090106 |
| Area Under the Concentration-Versus-Time Curve (AUC) of LY3090106 | Baseline through Day 85 | AUC of LY3090106 |
Countries
United States
Outcome results
None listed